MeDevIS PLATFORM

Source: WHO

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Context

• The World Health Organization (WHO) has launched the Medical Devices Information System (MeDevIS), an innovative online platform.

Details

• MeDevIS is the first global open-access clearinghouse for information on medical devices, aiming to support governments, regulators, and users in the decision-making process related to the selection, procurement, and use of medical devices for diagnostics, testing, and treatment of various diseases and health conditions.
• This is the first time WHO has developed such a global repository on medical devices, based on its experience with the WHO Priority Medical Devices List (MDL), which itself was based on the experience of creating the WHO Essential Medicines List (EML).
• Approaching its 50th anniversary in 2025, EML is regarded as a pillar of public health in countries across the world, supporting health progress and touching billions of lives.

Aspect	WHO Priority Medical Devices List (MDL)	WHO Essential Medicines List (EML)
Purpose	To identify critical medical devices needed for safe, effective, and quality health services.	To list essential medicines that address the priority health needs of the population.
Scope	Includes diagnostic, therapeutic, and supportive devices across various health conditions.	Covers medicines for primary, secondary, and tertiary care levels for various diseases.
Historical Background	The concept emerged in 2017 to support countries in providing essential health services.	The first list was published in 1977 with 208 medicines to standardize and improve global health care.
Frequency of Updates	Periodically updated based on advancements and health needs.	Updated every two years by an expert committee.
Criteria for Inclusion	Devices are selected based on safety, efficacy, cost-effectiveness, and public health relevance.	Medicines are chosen for their relevance, efficacy, safety, and cost-effectiveness.
Structure	Divided into categories like diagnostics, anesthesia, surgery, and laboratory services.	Divided into core and complementary lists based on essential health needs and resources required.
Current Edition	As of 2023, the list is periodically reviewed with the latest recommendations.	The 23rd edition was released in 2023, with 591 drugs and 103 therapeutic equivalents.
Impact	Assists countries in planning and providing essential medical devices to improve healthcare delivery.	Guides national policies and procurement, promoting access to essential medicines worldwide.
Implementation	Adaptable to various health system contexts, focusing on the most critical health needs.	Countries use it to develop their national lists, reflecting local priorities and health conditions.

Key Features

• Comprehensive Database:
  • Device Types:The MeDevIS platform includes information on 2301 types of medical devices used for a broad range of health issues, including reproductive, maternal, newborn, and child health, noncommunicable diseases (e.g., cancer, cardiovascular diseases, diabetes), and infectious diseases (e.g., COVID-19).
  • Device Details:Users can access detailed information on each device, including type, intended use, level of healthcare systems supporting the device, scope, and required infrastructure.
• Global Accessibility:
  • Open Access:The platform provides open access to its repository, making it a valuable resource for stakeholders worldwide.
  • International Naming Systems:MeDevIS references two international naming systems: the European Medical Device Nomenclature (EMDN) and the Global Medical Device Nomenclature (GMDN). These systems facilitate registration, regulatory approval, procurement, supply, inventory management, tracking, and pricing of medical devices.
• Simplified Information Retrieval:
  • Single Platform:Replaces the need for paper-based literature searches across multiple publications with non-standard device names.
  • Standardized Naming:Aims to simplify the naming of medical devices, making it easier for users to find reliable information.
• Support for Policymakers:
  • National Policy Development:Useful for national policymakers to develop or update national lists for the procurement of health technologies and devices.
  • Health Insurance and Reimbursement:Assists agencies in developing health insurance and reimbursement policies for patients.

Benefits

• Enhanced Decision-Making:
  • Provides a single, reliable source of information for decision-makers, aiding in the selection and procurement of medical devices.
  • Supports healthcare practitioners and patients in navigating the growing complexity and number of medical technologies.
• Global Standardization:
  • Promotes global standardization of medical device information through the use of EMDN and GMDN.
  • Facilitates international collaboration and harmonization of regulatory practices.
• Improved Access to Medical Technologies:
  • Especially beneficial for resource-limited settings by providing critical information that can improve access to life-saving medical technologies.
  • Contributes to the progress towards universal health coverage.

Challenges

• Data Privacy and Security:
  • Ensuring the security and privacy of sensitive medical device information is paramount.
  • The platform employs advanced security measures to protect data integrity.
• User Training and Adoption:
  • Adequate training and user support are essential to maximize the platform’s effectiveness.
  • Continuous engagement with stakeholders to improve the platform based on user feedback.
• Integration with Existing Systems: Integrating MeDevIS with existing healthcare and regulatory systems can enhance its functionality and user adoption.

Sources:

WHO

PRACTICE QUESTION Q: Consider the following statements regarding the MeDevIS platform: MeDevIS (Medical Devices Information System) is an online platform developed by WHO to monitor and report adverse events related to medical devices globally. MeDevIS provides real-time data on the safety and effectiveness of medical devices, facilitating regulatory actions and improving patient safety. MeDevIS is primarily focused on tracking the development and deployment of medical devices for space missions by international space agencies. Which of the statements given above is/are correct? a) 1 and 2 only b) 1 and 3 only c) 2 and 3 only d) 1, 2, and 3 Answer: a)